6935 Sprint Quattro Secure S
Defibrillation
6935 Sprint Quattro Secure S
ALL
Information

Device Survival Probability

6935_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr                
% Survival 99.5 99.3 98.9 98.6 98.5 98.1 97.5 96.8 95.9 94.7 94.3 93.9 93.3                
#   2415 1976 1626 1330 1125 968 807 678 571 432 248 143 57                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2977
Cumulative Months of Follow-Up 164563
Number of Leads Active in Study 720
Information 67

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 24
Extra Cardiac Stimulation 1
Failure to Capture 7
Failure to Sense 1
Impedance Out of Range 9
Lead Dislodgement 8
Oversensing 9
Other 6
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 35
Failure to Sense 15
Impedance Out of Range 28
Insulation Breach 1
Lead Dislodgement 68
Oversensing 67
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants67061
Estimated Active USA Implants39156
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution208992
Information

USA Returned Product Analysis

Conductor Fracture 470
Insulation Breach 13
Crimp/Weld/Bond 0
Other 44
Information

WW Returned Product Analysis

Conductor Fracture 866
Insulation Breach 32
Crimp/Weld/Bond 0
Other 80
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/One Coil
More
Serial Number Prefix TAU
Lead Body Diameter 8,2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
Hide this content

Data as of December 1, 2023

www.medtronic.com/productperformance 951051